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Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01448057
First received: October 5, 2011
Last updated: November 11, 2014
Last verified: November 2014
  Purpose

The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).


Condition Intervention Phase
Upper Respiratory Tract Infection
Nasal Congestion
Rhinorrhea
Sneezing
Drug: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Drug: Paracetamol (500 mg) tablets
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Investigator-Blind Study to Compare Three Days of Treatment With Paracetamol (500 mg) / Dimethindene Maleate (1 mg) / Phenylephrine Hydrochloride (10 mg) Tablets Versus Paracetamol 500 mg Alone in the Treatment of Nasal Congestion and Other Symptoms Due to Cold and Flu

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Physician Global evaluation of effectiveness on Nasal Symptoms [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]
    The Physician will measure the reduction of Nasal Symptoms (Nasal Congestion, Sneezing, and Rhinorrhea) on day 2


Secondary Outcome Measures:
  • Sum of subject self assessment using a 100 mm Visual Analog Scale [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]
    Subject will assess Nasal Symptoms using a 100 mm Visual Analog Scale


Estimated Enrollment: 244
Study Start Date: July 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Drug: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Active Comparator: Arm B
Paracetamol (500 mg) tablets
Drug: Paracetamol (500 mg) tablets
Paracetamol (500 mg) tablets

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Inclusion criteria:

    • acute URTI, diagnosed by a health care professional at the study site, with the following symptoms having started within 72 hours before the screening/baseline Visit: nasal congestion, sneezing, and rhinorrhea.

  • Exclusion criteria:

    • Use of other investigational drugs within 30 days or 10 half-lives before enrollment, whichever is longer.
    • History of or known hypersensitivity to any of the study drugs, excipients or to drugs of similar chemical classes.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448057

Contacts
Contact: Anna Grinienko 9735038000

Locations
Brazil
Santa Casa De Misericordia De Belo Horizonte - Avenida Francisco Sales 1111, Santa Efigenia Not yet recruiting
Belo Horizonte/MG, Brazil, 30150-221
Contact    55 31 3238 8849      
Sociedade Campineira De Educacao E Instrucao - Rodovia Dom Pedro I, KM 136 Parque das Universidades Not yet recruiting
Campinas/SP, Brazil
Contact    55 19 3343 8577      
Instituto de Ensino e Pesquisa Clínica do Ceará, Rua Coronel Jucá, 1952 - Dionísio Torres - Recruiting
Fortaleza/CE, Brazil, 60170-320
Contact    +55 85 3257 9646      
Polonio Clinica De Servicios Medicos EM Gastroenterologia E Cirurgia Toracica S/S LTDA - ME, Rua Major Alfredo Servulo de Oliveira Romao, 103, Chacara Braz Miraglia Not yet recruiting
Jau/SP, Brazil, 17210-070
Contact    55 14 3035 2812      
Hospital Sao Lucas da PUCRS , Ave. Ipiranga 6690 Withdrawn
Porto Alegre/RS, Brazil, 90610-000
Associacao Fundo De Incentivo A Pesquisa - AFIP - Rua Marselhesa 500 - Vila Clementino Recruiting
Sao Paulo, Brazil
Contact    55 11 5908 7081      
: Lal Clinica Centro de Pesquisa e Desenvolvimento Ltda, Rua General Osório, 503, Vila Martina / Valinhos Completed
São Paulo, Brazil, 13271-130
Sponsors and Collaborators
Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01448057     History of Changes
Other Study ID Numbers: 381-A-301
Study First Received: October 5, 2011
Last Updated: November 11, 2014
Health Authority: Brazil: Agência Nacional de Vigilância Sanitária do Ministério da Saúde do Brasil - ANVISA/MS

Keywords provided by Novartis:
Paracetamol
dimethindene maleate
phenylephrine hydrochloride
cold and flu symptoms

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Acetaminophen
Dimethindene
Maleic acid
Oxymetazoline
Phenylephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Anti-Allergic Agents
Antipruritics
Antipyretics
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Molecular Mechanisms of Pharmacological Action
Mydriatics
Nasal Decongestants
Neurotransmitter Agents

ClinicalTrials.gov processed this record on November 27, 2014